What to monitor in a patient with moderate to severe plaque psoriasis or psoriatic arthritis on Otezla (apremilast)?

Monitoring Parameters for Patients on Otezla (Apremilast)

Otezla requires minimal laboratory monitoring compared to traditional systemic therapies, but specific clinical parameters must be tracked regularly, particularly gastrointestinal symptoms, mood changes, and body weight. 1

No Routine Laboratory Monitoring Required

• Apremilast does not require baseline or ongoing laboratory monitoring (no CBC, liver function tests, renal function tests, or lipid panels needed), which distinguishes it from traditional systemic agents like methotrexate and cyclosporine 2
• This represents a significant practical advantage over biologics and conventional DMARDs that require extensive laboratory surveillance 2

Essential Clinical Monitoring Parameters

1. Gastrointestinal Symptoms (Highest Priority)

• Monitor for diarrhea and nausea, particularly within the first 2-4 weeks of treatment 1, 3
• Diarrhea occurs in ≥5% of patients and typically develops within 2 weeks of initiation 1, 4, 3
• Most GI symptoms resolve spontaneously within 4 weeks without dose adjustment 4, 3
• If severe diarrhea, nausea, or vomiting develops, consider dose reduction or temporary suspension 1
• Watch for chronic diarrhea leading to malnutrition, which may necessitate discontinuation (rare but reported) 4

2. Body Weight Monitoring

• Monitor weight regularly throughout treatment 1
• Weight loss can occur as an adverse effect of apremilast 1, 5
• If unexplained or clinically significant weight loss occurs, evaluate the cause and consider discontinuation 1

3. Depression and Mood Changes

• Advise patients, caregivers, and families to monitor for emergence or worsening of depression, suicidal thoughts, or other mood changes 1
• Carefully weigh risks versus benefits in patients with a history of depression and/or suicidal ideation 1
• Instruct patients to contact their healthcare provider immediately if mood changes occur 1

4. Upper Respiratory Tract Infections

• Monitor for upper respiratory tract infections and nasopharyngitis, which occur in ≥5% of patients 1, 3
• These are typically mild to moderate and self-limiting 3

5. Headache Assessment

• Headache (including tension headache) occurs in ≥5% of patients 1, 3
• Usually mild to moderate in severity and manageable with standard interventions 3

Special Population Considerations

Severe Renal Impairment

• Patients with severe renal impairment (CrCl <30 mL/min) require dose reduction to 30 mg once daily due to increased systemic exposure 1
• No specific renal function monitoring protocol is mandated beyond baseline assessment 1

Drug Interaction Monitoring

• Avoid concurrent use with strong CYP450 enzyme inducers (rifampin, phenobarbital, carbamazepine, phenytoin) as they may cause loss of efficacy 1
• Review medication list at each visit for potential interactions 1

Clinical Pitfalls to Avoid

• Do not discontinue therapy prematurely for mild GI symptoms that typically resolve within 4 weeks; most cases do not require dose adjustment 4, 3
• Do not assume apremilast requires the same intensive laboratory monitoring as methotrexate or cyclosporine—this is unnecessary and increases healthcare costs 2
• Do not overlook psychiatric history during initial evaluation—this is critical for risk stratification 1